Can Research Subjects of Clinical Trials in Developing Countries Sue Physician-Investigators for Human Rights Violations?

Abstract:     
In 1998, the Centers for Disease Control and Prevention (CDC) unexpectedly announced that it was calling off the maternal-child HIV transmission clinical trials in developing countries, stating that it was satisfied with the results from the drug trial in Thailand. The announcement brought to an abrupt end a clinical trial that was ongoing in eleven countries but had been surrounded by controversy since its inception.

The clinical trial had sparked numerous ethical debates, as some of the pregnant women who served as research subjects received a placebo in order to test the efficacy of a short course of AZT (also called zidovudine) in preventing perinatal transmission of HIV. Proponents of the study said that the research was necessary and was responsive to the existing economic and health conditions in developing countries. Critics countered that the use of placebos was unethical when a known effective treatment was available. This Article does not focus on the ethical debate, rather it aims to examine the legal question: can a woman who served as a research subject and whose child is now HIV-positive bring a lawsuit on behalf of the child against the physician-investigators?

The author examines the prospects for bringing such a lawsuit against the researchers using the framework of the Alien Tort Claims Act. In doing so, the author demonstrates that the major principles of medical experimentation involving human subjects, particularly the requirement of the informed consent of research subjects, have risen to the level of international customary law and therefore could provide the basis of a claim.

The author states that, while such a claim does not mean an end to all clinical trials using placebos, it does suggest that the medical research community needs to develop stronger and clearer guidelines and more strictly enforce these standards. In the absence of this, the author notes, human rights law can provide an alternative means of protecting the most vulnerable of populations.

Number of Pages in PDF File: 32

Keywords: Human Rights, International Law, Clinical Trials, Medical Experimentation, Drug Trials, Alien Tort Claims Act

JEL Classification: K3

Accepted Paper Series